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510(k) K923397

Device
SINGLE DOSE GAS INJECTOR
Applicant
ESCALON MEDICAL TREK
510(k) number
K923397
Product code
BXX  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-14
Date received
1992-07-10
Regulation
868.2620
Classification name
Calibrator, Pressure, Gas
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RONALD HUENEKE
Address
820 Swan Dr. Mukwonago WI US 53149 53149

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BXX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K875075RT-200 COMPUTER INTERFACETimeter Instrument Corp.1988-04-21
K850029UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CALUtah Medical Products, Inc.1985-04-29
K822746RT-200 CALIBRATION ANALYZERTimeter Instrument Corp.1982-10-13
K801256NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAYKleen Test Products1980-06-04
K801257NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.Kleen Test Products1980-06-04
K801258NEEDLE COUNTER-SURE COUNT/10 COUNTKleen Test Products1980-06-04
K791294SPIROCALEquilibrated Bio Systems, Inc.1979-08-16
K780981PORTABLE PNEUMATIC CALIBRATOR 65-150Pennwalt Corp.1978-08-02
K780838PERCIMicro Tronics Corp.1978-07-17

Legacy Summary#

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FDA Review#

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